Pioneering GSK study provides important new data on the effectiveness of Relvar Ellipta (FF/VI) when used in everyday clinical practice

The highly anticipated results from the Salford Lung Study were announced by GSK on 24th May 2016.

Healthcare professionals from eight organisations across Greater Manchester have collaborated to deliver the initial results of the Salford Lung Study (SLS). The study involved over 2,800 consenting patients, supported by 80 GP practices and 130 pharmacies in Salford and the surrounding Greater Manchester area.

This ground-breaking study, sponsored by GSK, examined the safety and effectiveness of a new treatment for chronic obstructive pulmonary disease (COPD). This was delivered in partnership with NorthWest EHealth (NWEH), The University of Manchester, Salford Royal NHS Foundation Trust, CK Aspire, Salford CCG, University Hospital South Manchester, South Manchester CCG and NIHR Clinical Research Network: Greater Manchester.

It is the world’s first digitally enhanced Randomised Controlled Trial (RCT) to include a broad and inclusive population of patients in an everyday clinical practice setting, embracing a novel approach to clinical trial design. This provides researchers with a breadth of clinical data that demonstrates the healthcare interactions of the everyday lives of patients and the way they use their medicines.

Conventional RCTs are usually conducted following strict inclusion criteria, which often exclude those patients with other multiple conditions. SLS was designed to include those patients who would often be excluded from a traditional randomised trial, for example individuals also being treated for other chronic diseases. This inclusive approach is important because it is more realistic of everyday practice and is therefore representative of a much wider patient population. The data provided by SLS will complement the existing data provided by the conventional RCT.

This collaborative study was placed in Salford because of the existing infrastructure of integrated electronic health medical records. The study relied on bespoke software, developed by NWEH and securely hosted within the NHS network that integrated the electronic medical records of consenting patients across all of their everyday interactions with their GPs, pharmacists and hospitals. This linked database system allowed close monitoring of patients’ safety in near real-time, but with minimal intrusion into their everyday lives.

By collecting healthcare information both quickly and efficiently, in line with best practice guidelines for security of patient data, the system offers responsiveness to patient safety, high quality data and short timelines for studies.

This digitally enhanced RCT design is a new and innovative approach to clinical trials; it is anticipated that the study methodology and underpinning technology could be used in future studies, not just in Greater Manchester but worldwide.

Sir David Dalton, Salford Royal Foundation Trust, Chief Executive, said: “Salford has a rich history of pioneering health care and is now building one of the most innovative environments in the UK for conducting patient-focused health research and translating it into patient benefit. We are delighted that this ground-breaking study has taken place in Salford as a result of our close collaboration with NorthWest EHealth, GSK and Salford CCG. Together we are at the forefront of the development of healthcare focused on the needs of patients by providing modern, innovative and cost-effective care, embracing technologies, and ensuring that patients have the opportunity to take part in research. The combination of our pioneering approach to integrated care and our integrated information systems have made this study possible.”

Professor Martin Gibson, NorthWest EHealth, Chief Executive, said: “This is not about Big Data, this is about understanding the way patients interact with medications in their everyday lives. Our unique technology supports understanding of NHS data to bring the right drugs to market quicker, whilst providing timely and accurate information on safety and cost for payers and patients alike.”

NorthWest EHealth’s Contribution to the Salford Lung Study

NWEH is a UK based Academic and NHS collaboration which specialises in leveraging existing Electronic Health Records (EHR) to develop medicines more quickly, with improved safety monitoring for the benefit of patients, pharmaceutical companies, and payers.

NWEH has led delivery on all the validated IT and EHR data aspects of the Salford Lung Study (SLS) robust Randomised Clinical Trial (RCT).

NWEH has demonstrated that it is able to help improve patient recruitment, reduce study costs, increase patient safety (through near real-time safety monitoring), and provide better clinical trial data that has greater breadth and depth (i.e. all Primary, Secondary and Pharmacy EHR Data for study subjects both during, and before, their time on the trial).

The technologies that NWEH have developed for use of existing EHR for robust RCTs, combined with their secure management of data within the N3*, are proven, established and replicable not only in the UK but in other digitised health economies across the globe.